Kornimate/medical-research-clean huggingface dataset:
a study on tumor budding guiding individualized surgical planning of early-stage oral squamous cell carcinoma.

Conditions: Carcinoma, Squamous Cell

Summary: the purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.

oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases. lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy. recently, cervical lymph node dissection(clnd) is performed in the presence of oral squamous cell carcinoma. however, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial. clnd will represent over-treatment in some case of early-stage oral squamous cell carcinoma. therefore, how to accurately predict whether a patient should be performed clnd is important. our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma. the purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.

Eligibility criteria:
inclusion criteria: 1. han race; 2. oral squamous cell carcinoma is confirmed by pathology; 3. the section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa; 4. the primary lesion is no more than 4cm; 5. do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and mri; 6. patients and families agree to participate in the study; 7. patients do not have cognitive disorders. exclusion criteria: 1. do not meet the inclusion criteria; 2. the primary lesion is more than 4cm or invade adjacent tissues; 3. do not review on schedule; 4. patients receive not only surgical procedures, but other antineoplastic treatment; 5. there are serious adverse events after operation; 6. patients quit the study voluntarily; 7. patients quit the study because of physical condition.

Keywords: oral squamous cell carcinoma tumor budding cervical lymph node dissection
pleotropic effect of new oral anticoagulants

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. this study was designed to determine the efficacy of noac therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of af subjects.

the properties of oral, direct inhibitors of factor xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. preclinical studies have provided evidences for the effects of direct factor xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . therefore, this study evaluates the protective effects of naoc with the reactive hyperemia peripheral arterial tonometry (rh-pat) measurements reflecting endothelial function by endo-pat2000 and intima-media thickness (imt) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.

Eligibility criteria:
inclusion criteria: * cha2ds2-vasc score above 2 exclusion criteria: * severe peripheral arterial disease (greater than a fontaine iib category) * grade 4 or higher cerebral infarction on the modified rankin scale * proven coronary artery disease by coronary angiogram * severe hepatic or renal dysfunction * uncontrolled congestive heart failure * uncontrolled hypertension or diabetes mellitus * hematologic disorders * allergy or hypersensitivity to the investigational drugs * pregnant or lactating women or women wishing to become pregnant

Keywords: anticoagulant atherosclerosis endothelium
determination of ed90 of intrathecal lidocaine for adequate anesthesia for elective cervical cerclage surgery

Conditions: Pregnancy; Surgery; Pain

Summary: cervical incompetence complicates approximately 1 in 500 pregnancies . those women with cervical incompetence are at risk for second trimester spontaneous abortion and preterm labor. cervical cerclage reduces these risks but must be performed under general or neuraxial anesthesia. some anesthesiologists prefer neuraxial anesthesia, as it reduces fetal exposure to medications and avoids the risks associated with loss of maternal airway reflexes under general anesthesia. spinal anesthesia, in particular, has the added advantage of being technically simple while still providing a rapid, dense sensory block. for cerclage placement, patients require a sensory block from the t10 to s4 dermatome in order to cover sensation from the cervix as well as the vagina and perineum. patients presenting for cerclage under spinal anesthesia pose a dosing challenge given the physiologic changes associated with pregnancy. as women progress with their pregnancy, they require lower doses of intrathecal local anesthetic to achieve similar block level. multiple studies have demonstrated that these changes start during the second trimester. inadequate sensory coverage with a spinal anesthetic typically necessitates conversion to general anesthesia, causing additional time wasted and added risk to the patient and fetus. anecdotally, this is the reason why some anesthesiologists choose general anesthesia for patients undergoing cerclage over a spinal anesthetic. as there is currently no literature determining the correct dosage for these patients, we propose a dose-response study to determine the ed90 of intrathecal lidocaine for adequate anesthesia for elective cervical cerclage placement.the findings of this study will help determine the minimum dose of intrathecal lidocaine necessary to provide adequate spinal anesthesia for cervical cerclage for 90% of women. this will help decrease the frequency of inadequate anesthesia for cervical cerclage.


Eligibility criteria:
inclusion criteria: * any patient who is at least 18 years old * asa physical class i or ii * bmi \<40 kg/m2, * presents for elective cervical cerclage during their first or second trimester of pregnancy will be eligible to participate. exclusion criteria: * any patient who is not a candidate for neuraxial anesthesia (including coagulopathy, * local skin infection, uncorrected hypovolemia) * allergy to lidocaine or fentanyl * chronic opioid user * history of failed neuraxial anesthesia or analgesia, * had prior spine surgery * can not assume a sitting position for spinal anesthesia due to risk of amniotic membrane rupture

Keywords: pain surgery pregnancy anesthesia
a tolerance and pharmacokinetic study of trodusquemine in healthy volunteers

Conditions: Obesity

Summary: the purpose of this study is to evaluate the safety and tolerance of single intravenous (through a vein) doses of trodusquemine. different amounts of trodusquemine will be given to each volunteer group throughout the study. another purpose is to evaluate the pharmacokinetics (pk - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine. finally, this study will also determine whether trodusquemine has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).


Eligibility criteria:
inclusion criteria: * male or female subjects, between 18 and 55 years old (inclusive); * body mass index (bmi) of 27-40 kg/m2; exclusion criteria: * likely allergy or sensitivity to any components of trodusquemine for injection based on known allergies to drugs of the same class, or which, in the opinion of the principal investigator, suggests an increased potential for an adverse hypersensitivity to trodusquemine hcl; * any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications; * any subject with a history of severe allergy or bronchial asthma;
effect of virtual reality on patient outcomes and satisfaction in total knee replacement

Conditions: Knee Replacement; Knee Replacement Surgery; Postoperative Pain, Acute; Anxiety, Preoperative; Pain Management; Virtual Reality

Summary: this study aims to evaluate the effectiveness of virtual reality (vr) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. investigators will assess the impact of preoperative vr training on anxiety levels, explore the effectiveness of relaxing and distracting vr videos for pain management after surgery, and determine the optimal timing for vr application by comparing different vr intervention times. our goal is to identify how vr can improve both the emotional and physical recovery process for patients undergoing knee replacement surgery.


Eligibility criteria:
inclusion criteria: * patients with an asa score of 1, 2, or 3 * elective unilateral total knee replacement surgery was planned, * patients who are able to read and write in turkish exclusion criteria: * using \>30 mg of oral oxycodone or equivalent daily * long-term opioid use (\>12 weeks) * substance use disorder * scheduled for emergency surgery * scheduled for revision surgery * requiring postoperative intensive care * patients with visual or hearing impairments * individuals experiencing motion-related nausea or dizziness * history of stroke or dementia * pregnant or breastfeeding women * patients with a history of epilepsy or seizures
fertility preservation in breast cancer patients

Conditions: Breast Neoplasms; Fertility

Summary: the purpose of this study is to evaluate efficiency and safety of controlled ovarian stimulation (cos) associated with an aromatase inhibitor (letrozole) for fertility preservation in breast cancer patients.

patients enrolled in this study undergo standard or "random start" ovarian stimulation with gonadotropins using antagonist protocol before the beginning of chemotherapy. ovulation is triggered in all patients with a gnrh agonist since amendment p2015/091 (decapeptyl 0,2mg). at oocyte retrieval, aspirated follicular fluid is separated from the flush medium for hormonal assays, and oocytes are denuded for icsi(intra cytoplasmic sperm injection) or vitrification. cumulus cells are collected for subsequent analysis of oocyte quality gene expression. a. primary objective of the study is to evaluate efficiency of letrozole associated ovarian stimulation for fertility preservation in breast cancer patients in terms of oocyte maturation rate. patients' results for primary endpoint are prospectively compared to infertile patients undergoing cos without letrozole. b. secondary objectives of the study aim to evaluate safety of the protocol: 1. estradiol and progesterone levels at ovulation triggering, ovulation and during luteal phase after oocyte retrieval (days 3 and 8) 2. the risk of disease relapse will be assessed by long-term follow-up of these patients (up to 5 years) as well as an evaluation of circulating tumoral dna before and after ovarian stimulation. 3. finally obstetrical outcomes will also be recorded.

Eligibility criteria:
inclusion criteria: * breast cancer female patients of less than 41 years old * addressed to fertility preservation unit before starting chemotherapy exclusion criteria: * metastatic breast cancer * known premature ovarian failure * basal fsh \> 20 iu(international unit) * surgical contra-indications

Keywords: fertility preservation letrozole ovarian stimulation
embolization of the middle meningeal artery with onyx™ liquid embolic system for subacute and chronic subdural hematoma

Conditions: Subdural Hematoma

Summary: the purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (mma) using the onyx™ liquid embolic system (les) for treatment of symptomatic subacute or chronic subdural hematoma (sdh)


Eligibility criteria:
inclusion criteria: * pre-morbid modified rankin score ≤3 * confirmed diagnosis of subacute or chronic subdural hematoma * completed informed consent * meets criteria for surgery or observation cohort exclusion criteria: * life expectancy \<1 year * unable to complete follow-up * pregnant, lactating, or has a positive pregnancy test at time of admission * diagnosed with acute sdh * potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for mma embolization * pre-randomized markwalder grading scale score ≥ 3 * unmanaged, uncontrolled bleeding disorders/blood diathesis * presumed septic embolus, or suspicion of microbial superinfection * known active covid-19 infection * ct or mri evidence of intra-cranial tumor or mass lesion contraindication to angiography * participation in another clinical trial * contraindicated for the use of onyx™ les * cannot be taken off corticosteroids (intended to treat subacute or chronic sdh) for at least 90 days post-randomization
nutritional status after sleeve gastrectomy in morbid obesity: 6-month study

Conditions: Bariatric Surgery Candidate; Gastrostomy; Obesity

Summary: this study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. preoperative and postoperative biochemical parameters along with anthropometric measurements will assess.

objective: this retrospective study aims to evaluate the nutritional status of morbidly obese patients in the first six months following sleeve gastrectomy. methods: the study is planned as a retrospective analysis. the data of 76 patients aged 19-64 years who underwent bariatric surgery and were monitored by a dietitian for at least six months will be included in the study. preoperative and postoperative biochemical parameters and anthropometric measurements of the patients will be collected and analyzed. detailed description: the study will assess the changes in nutritional status, including body weight, bmi, fasting blood glucose, hba1c, homa-ir, iron levels, vitamin d levels, and lipid profile (triglycerides, ldl, hdl) among morbidly obese patients in the first six months following sleeve gastrectomy. preoperative and postoperative measurements will be compared to evaluate the impact of surgery on these parameters. conclusion: results will be analyzed and interpreted after data collection is completed, and conclusions will be drawn accordingly.

Eligibility criteria:
inclusion criteria: * data of patients aged 19-64 years * data of patients with bmi ≥ 40 kg/m2 or bmi ≥ 35 kg/m2 and at least one comorbidity such as obesity-related hypertension, dyslipidemia, type 2 diabetes mellitus, and sleep apnea * data of patients who underwent sleeve gastrectomy * volunteering exclusion criteria: * data of patients who were not deemed suitable for surgery by the physician and to whom a surgical technique different from sleeve gastrectomy was applied * data of patients who were not followed up by a dietitian for six months after surgery * data of patients with gastrointestinal inflammatory bowel disease * data of patients with psychiatric disorders diagnosed by a physician * data of patients with cancer, pregnant and lactating women, alcohol or drug addiction

Keywords: gastrectomy bariatric surgery nutritional status
pilot study for the evaluation of food choices in patients with inflammatory bowel diseases (mici2021)

Conditions: Inflammatory Bowel Diseases

Summary: this project is a pilot study exploring the effects of dietary choices and quantitative digestion of gluten ingested by individuals with ibd compared to a control population. the aim of the study is to evaluate for the first time in an italian population of subjects with ibd the presence of a diet based on gfd (gluten free diet).

subjects with ibd will be recruited among the patients referred to the ibd clinic of the policlinico of milan. these patients are subject to annual check-ups during which, where possible, they will be asked to sign an informed consent. these patients are subjected during the visits of normal clinical follow-up to: * questionnaire on eating habits for the patient with ibd versus control patients; * modified food habits frequency questionnaire (ffq), validated for the celiac population. the questionnaire assesses the extent, frequencies of consumption and quantity of gluten-containing foods in a year; this, in order to estimate the average introduction of gluten through the diet versus control patients; * anthropometric and plicometric analysis; * validated clinical activity questionnaires for rcu (ulcerative rectocolitis) and cd (chron disease) (mayo score and harvey-bradshaw index).

Eligibility criteria:
inclusion criteria: * age: 18 years * gender: women and men * patients who have been diagnosed with ibd for at least 12 months * patients who have signed an informed consent exclusion criteria: * pregnancy status * patients not suffering from the two main forms of ibd, i.e. cd or rcu (unclassified ibd colitis, collagenous colitis, lymphocytic colitis will be excluded).

Keywords: ulcerative rectocolitis crohn disease gluten-free diet ibd nutrition
efficacy of dietary fiber supplementation (soloways) in patients with specific genetic polymorphisms

Conditions: Obesity

Summary: this randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (fto, mc4r, lep, lepr). participants were adults aged 18-65 with a bmi ≥ 25 and confirmed genetic predispositions. the study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. primary outcome was body-weight change in %. the study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.


Eligibility criteria:
inclusion criteria: * confirmed presence of one or more specified gene polymorphisms (fto, mc4r, lep, lepr). * overweight or obese status (bmi ≥ 25). exclusion criteria: - bmi \< 25

Keywords: obesity supplements body mass index overweight
weight changes among martinican prisoners

Conditions: Weight Gain; Weight Loss

Summary: assessment of body weight change among prisoners in martinique between admission in jail and 3 months later expressed as a percentage of admission weight. intensity of physical activities, nutrition intakes and psychological state are also studied to describe associated factors to body weight change.

several studies described how weight of prisoners may vary during incarceration. taking or losing weight both have health consequences but are also a warning signal for several pathologies. female prisoners are more likely getting fat, data are rare and contradictory about male prisoners. a single study was conducted in mainland france and including few men. furthermore, martinique is a department where the prevalence of overweight and diabetes in the general population are higher than the national average. prisoners most often have socio-demographic featuring and morbidity different from the general population (more men, some over-represented age groups, addictive behaviors and more frequent mental health problems ...). aspects nutritional information is less often documented. what about the weight variation of people held in martinique? is incarceration always accompanied by weight gain? what are factors associated with weight variation? this study aims to answer to those questions by including all men newly admit in the only martinican jail aged from 18 to 44 years and consenting. during admission medical consultation, prisoners will fill guided by the investigator doctor of self-questionnaires of the evaluation of the level of physical activity, assessment of nutritional intakes and psychological state before incarceration. measurement of weight and other anthropometrics data will be done, investigator doctor will collect data about socio-economic featuring, medical history and treatment. three months later, a research technician will interview included prisoners in their life place and guide them to fill new self-questionnaires of the evaluation of the level of physical activity, assessment of nutritional intakes and psychological state during incarceration. measure weight and other anthropometrics data and collecting data about new treatment, stopping tobacco will be done during this interview.

Eligibility criteria:
inclusion criteria: * all men newly incarcerated in martinican jail during inclusion period * age between 18 and 44 years old * having given his consent exclusion criteria: * female * 44 years old and up * not understanding or speaking french or english

Keywords: prisoners body weight male french west indies epidemiology
clinical trial to evaluate the safety, tolerability and efficacy of ct303 in patients with ards

Conditions: Acute Respiratory Distress Syndrome

Summary: evaluate the safety, tolerability, efficacy and pharmacodynamics\&pharmacokinetic properties of ct303 in patients with ards.

this study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial. the primary purpose is to evaluate the safety and tolerability of ct303 and the secondary purpose is to evaluate the efficacy of ct303 in patients with ards. and the exploratory purpose is to evaluate pharmacodynamics properties pharmacokinetic properties of ct303 in patients with ards.

Eligibility criteria:
inclusion criteria: * ≥ 19 years old * patients who meet the ards criteria according to the berline definition 1. within 1 week of a known clinical insult or new or worsening respiratory symtoms 2. bilateral opacities not fully explained by effusions, loar/lung collapse, or nodules 3. respiratory failure not fully explained by cardiac failure or fluid overload 4. oxygenation corresponding to mild, moderate, severe * patients requiring positive pressure ventilation using an endotracheal tube * patients or legal representative signed informed consent form exclusion criteria: * greater than 96 hours since first meeting ards criteria * patients who was previously administered mesenchymal stem cell therapy products or other cell therapy products * patients with the following medical history or comorbid condition 1. medical history 1. patients who had an organ transplant or bone-marrow transplantation 2. patients who had a pneumonectomy 3. a maligant tumor within 5 years 4. a deep vein thrombosis or pulmonary embolism with in 6 months 5. a trauma within 7 days 2. comorbid condition 1. patients with ast or alt exceeding 5 times the upper limit of the normal range 2. egfr ≤ 29ml/min or patients requiring continuous renal replacement therapy 3. severe chronic respiratory disease 4. who functional assessment class iii/iv pulmonary hypertension 5. severe cardiac insufficiency 6. qtc \> 480msec 7. chronic underlying diseases * viral hepatitis type b or type c, or positive hiv test * patients using extracorporeal life support devices or high-frequency oscillatory ventilation * moribund patients expected to die within 48 hours * patients who refuse or are likely to refuse life-sustaining treatment * fertile women or men who disagree a continence and a contraception * patients with a history of hypersensitivity reaction * patients participating in clinical trials within 4 weeks * patients determined by the investigator to be inappropriate to participate in this clinical trial

Keywords: ards